'RemsimaSC' Targeting US New Drug Market Introduces Phase 3 Clinical Trial Results at Asian Conference

Published 14 Apr.2023 08:50(KST)

Celltrion announced on the 14th that it participated in the 11th Asia Inflammatory Bowel Disease Conference (AOCC) and the 6th International Conference of the Korean Association for the Study of Intestinal Diseases held at BEXCO in Busan from the 13th to the 15th, where it unveiled the global Phase 3 clinical trial results of 'Remsima SC' in a poster presentation.

Remsima SC Model <br><span class="photo">Photo by Lee Chunhee</span>

Remsima SC Model
Photo by Lee Chunhee

AOCC is an international academic conference where IBD experts from Asian regions such as Japan, China, and Taiwan gather to share the latest insights with the goal of improving the quality of life for patients with inflammatory bowel disease (IBD). Since its first event in Tokyo in 2013, it has been held annually in Asian countries.

Remsima SC (development code CT-P13 SC), an autoimmune disease treatment, was developed as a subcutaneous (SC) formulation of infliximab. All existing infliximab drugs, including the original 'Remicade,' were intravenous (IV) formulations. However, after listening to the opinions of local European medical professionals, Celltrion Chairman Seo Jung-jin judged that there was a high need for an SC formulation to enhance convenience and personally directed its development, resulting in the first and only infliximab SC formulation drug to date. Already launched in Europe, the product is rapidly expanding its market share amid favorable reviews from local medical professionals. According to IQVIA and Celltrion Healthcare, Celltrion Healthcare, which handles overseas sales of Remsima SC, the drug achieved a 14.3% market share in the five major European countries (EU5) as of the third quarter of last year, continuing its upward trend.

The research results disclosed this time are clinical data conducted for the purpose of obtaining new drug approval for Remsima SC in the United States. Although developed as a biosimilar (biologic drug copy), the U.S. Food and Drug Administration (FDA) highly valued the potential of Remsima SC and recommended filing a new drug application, which is currently under review. Approval is expected by the end of this year.

Celltrion conducted a study involving 343 Crohn’s disease (CD) patients and 438 ulcerative colitis (UC) patients. After administering Remsima IV formulation up to week 6, patients who showed clinical response to Remsima IV induction therapy were randomized in a 2:1 ratio at week 10 to receive either Remsima SC or placebo. The study confirmed statistical superiority in efficacy and safety of Remsima SC compared to placebo during maintenance therapy.

As a result, in the clinical trial conducted up to week 54 for Crohn’s disease patients, 62.3% of the treatment group achieved clinical remission, defined as Crohn’s Disease Activity Index (CDAI) below 150, compared to 32.1% in the placebo group. Endoscopic response was also higher in the treatment group at 51.1% versus 17.9% in the placebo group, with statistical significance demonstrated. Additionally, favorable outcomes were confirmed in secondary endpoints and safety.

Similarly, in the clinical trial conducted up to week 54 involving 438 ulcerative colitis patients, clinical remission regarding symptoms such as stool frequency and rectal bleeding was observed in 43.2% of the treatment group, compared to 20.8% in the placebo group. This study also achieved positive results in secondary endpoints and safety.

At the 'Meet the Experts' event held at the Celltrion Healthcare booth during the European Crohn's and Colitis Organisation (ECCO 2023) conference last month at the Bella Center in Copenhagen, Denmark, Professor Milan Lukas of Charles University in Czech Republic (Director of Iscare Hospital) gave a presentation on Remsima SC. According to Celltrion Healthcare, about 170 people gathered to listen to Professor Lukas's presentation that day.
[Photo by Lee Chunhee]

In February, Celltrion presented these clinical research results at the European Crohn’s and Colitis Organisation (ECCO), a leading European inflammatory bowel disease conference held in Copenhagen, Denmark, and confirmed a warm response from local medical professionals.

Additionally, at the AOCC venue, Celltrion Pharmaceutical, an affiliate of the Celltrion Group, will set up a promotional booth to introduce Remsima SC. Especially on the last day of the conference, the 15th, at a luncheon symposium hosted by Celltrion Pharmaceutical, domestic and international experts including current ECCO President Professor Laurent Peyrin-Biroulet will present the latest research results related to Remsima SC, including new clinical trials and real-world prescription cases in Europe and Korea.

A Celltrion representative stated, “Based on the competitiveness of Remsima SC proven through this clinical trial, we plan to complete U.S. approval without delay and do our best to enter the U.S. market. We expect that the global market share will further expand through synergy effects with the Remsima IV formulation.”